Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate the therapeutic utility of polidocanol across diverse indications, primarily vascular and structural lesions such as varicose veins, hemorrhoids, vascular malformations, benign thyroid cysts, and melanoma metastases. Sponsored by academic institutions, medical device entities, and professional organizations, these studies feature recruitment statuses ranging from active and completed to terminated or withdrawn. Specific protocols evaluate pharmacokinetic profiles and sclerotherapy outcomes across liquid and foam preparations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07276243 RECRUITING
Varicose Veins
Hospital Universitario Pedro Ernesto
 2026-03-24
NCT07561320 RECRUITING
Varicose Veins of Leg With Long Saphenous Vein Distribution; Varicose Veins of Lower Limb
Antonio Eduardo Zerati
 2026-05 PHASE4
NCT07793630 ACTIVE_NOT_RECRUITING
Telangiectasias; Reticular Veins; Chronic Venous Disease
University of Sao Paulo
 2026-09-01 PHASE4
NCT07606391 NOT_YET_RECRUITING
Keloid and Hypertrophic Scars
Sohag University
 2026-08-01
NCT06749665 NOT_YET_RECRUITING
Common Wart
Sohag University
 2024-12-20
NCT06132165 COMPLETED
Neurofibromatosis 1
Massachusetts General Hospital
 2024-03-01 PHASE1
NCT07320430 COMPLETED
Vascular Malformation
Ain Shams University
 2024-02-14
NCT05798936 UNKNOWN
Benign Thyroid Nodule; Thyroid Lump; Thyroid Cyst
Assiut University
 2023-04-01 PHASE4
NCT07307131 COMPLETED
Cutaneous Warts; Human Papilloma Virus (HPV)
Benha University
 2024-09-01 PHASE2
NCT06667570 COMPLETED
Varicose Veins
Lidiane Rocha
 2024-10-25
NCT06120036 COMPLETED
Neurofibromatosis 1
Massachusetts General Hospital
 2022-12-06 PHASE1
NCT06962813 COMPLETED
Varicose Veins Leg; Telangiectasias
Science Valley Research Institute
 2023-01-10
NCT06031740 UNKNOWN
Liver Cirrhosis; Internal Hemorrhoid
Institute of Liver and Biliary Sciences, India
 2023-09-07
NCT05807425 UNKNOWN
Hemorrhoids; Liver Cirrhosis
Universidade do Porto
 2023-03-31 PHASE2; PHASE3
NCT05633277 UNKNOWN
Venous Reflux; Venous Insufficiency; Venous Ulcer; Venous Disease
ProMedica Health System
 2020-09-30
NCT05798936 Not yet recruiting
Benign Thyroid Nodule|Thyroid Lump|Thyroid Cyst
Assiut University
 2023-04-01 Phase 4
NCT03754140 WITHDRAWN
Melanoma; In-Transit Metastasis of Cutaneous Melanoma
Melanoma Institute Australia
 2020-05-20 PHASE2
NCT02557542 TERMINATED
Varicose Veins
Imperial College London
 2015-10
NCT05586919 COMPLETED
Venous Malformation
Al-Azhar University
 2018-10-01
NCT04091763 COMPLETED
Hemorrhoids, Internal
Universidade do Porto
 2018-08-01 PHASE2
NCT03754140 Withdrawn
Melanoma|In-Transit Metastasis of Cutaneous Melanoma
Melanoma Institute Australia
 2020-05-20 Phase 2
NCT04188171 UNKNOWN
Hemorrhoids; Bleeding Disorder
Universidade do Porto
 2018-08-01 PHASE2; PHASE3
NCT04675177 COMPLETED
Hemorrhoids
Universidade do Porto
 2019-09-01 PHASE2; PHASE3
NCT03791775 COMPLETED
Second-degree Hemorrhoids
Societa Italiana di Chirurgia ColoRettale
 2019-01-02 PHASE2
NCT02988063 WITHDRAWN
Leg Ulcer; Veins, Varicose; Venous Ulcer; Reflux; Venous Reflux; Venous Leg Ulcer; Varicose Veins; Varicose Ulcer; Varicose Veins Leg
OhioHealth
 2017-04-10 PHASE4
NCT02657252 COMPLETED
Varicose Veins; Telangiectasis
UPECLIN HC FM Botucatu Unesp
 2015-01 PHASE4
NCT05468450 COMPLETED
Varicose Veins of Lower Limb
Societe Francaise de Phlebologie
 2015-07-01
NCT02154789 TERMINATED
Ganglion Cysts
University of Edinburgh
 2015-07-27 PHASE4
NCT06192472 COMPLETED
Varicose Veins
University of Surrey
 2013-04
NCT02054325 COMPLETED
Varicose Veins
UPECLIN HC FM Botucatu Unesp
 2012-09 PHASE4
NCT01197833 COMPLETED
Great Saphenous Vein Incompetence; Visible Varicosities
Boston Scientific Corporation
 2010-09 PHASE3
NCT01428076 COMPLETED
Varicose Veins
Boston Scientific Corporation
 2011-08 PHASE1
NCT01072877 COMPLETED
Varicose Veins
Boston Scientific Corporation
 2010-12 PHASE3
NCT01231373 COMPLETED
Varicose Veins
Boston Scientific Corporation
 2010-11 PHASE3
NCT01428076 Completed
Varicose Veins
Boston Scientific Corporation|BTG International Inc.
 2011-08 Phase 1
NCT01185951 UNKNOWN
Tendinopathy; Epicondylitis
Hannover Medical School
 2007-01 PHASE2
NCT00928421 COMPLETED
Varicose Veins
Boston Scientific Corporation
 2009-06 PHASE2
NCT00758420 COMPLETED
Varicose Veins
Boston Scientific Corporation
 2008-10 PHASE2; PHASE3
NCT00377910 COMPLETED
Chronic Achilles Tendinopathy
Northern Orthopaedic Division, Denmark
 2008-03 PHASE4
NCT00442364 COMPLETED
Varicose Veins
Boston Scientific Corporation
 2007-03 PHASE2
NCT00399451 UNKNOWN
Apnea; Snoring
Liaoyang Central Hospital
 2006-12 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-05)

Check the Polidocanol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Polidocanol functions as a non-ionic surfactant that directly incorporates into the endothelial cell membrane lipid bilayer, disrupting cellular integrity and precipitating rapid endothelial denudation. This localized endothelial collapse promotes vasospasm and intravascular thrombus formation, culminating in irreversible fibrous vessel ablation that reduces pathological vascular mass in varicose veins, hemorrhoids, and benign cysts.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.